FDA.reportPublic FDA data

Female Tonic

Manufacturer
Marco Pharma International LLC. | Nestmann Pharma GmbH
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:29:16

Label at a glance#

ProductFemale Tonic
Active ingredientALCHEMILLA XANTHOCHLORA FLOWERING TOP, GALIUM ODORATUM, MATRICARIA RECUTITA, VIOLA ODORATA, CINCHONA OFFICINALIS BARK, MENTHA PIPERITA, ROSMARINUS OFFICINALIS FLOWERING TOP, VALERIAN, CHAMAELIRIUM LUTEUM ROOT, CHASTE TREE, BLACK COHOSH, CONVALLARIA MAJALIS, SAFFRON, CYCLAMEN PURPURASCENS TUBER, TURNERA DIFFUSA LEAFY TWIG, GOLDENSEAL, CAULOPHYLLUM THALICTROIDES ROOT, LILIUM LANCIFOLIUM FLOWERING TOP, PACKERA AUREA, DELPHINIUM STAPHISAGRIA SEED, NAJA NAJA VENOM
Label structure2 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alchemilla Vulgaris 1x

Asperula Odorata 1xHPUS

Chamomilla 1xHPUS

Viola Odorata 1xHPUS

Cinchona Officinalis 2x

Mentha Piperita 1xHPUS

Rosmarinus Officinalis 1xHPUS

Valeriana Officinalis 1xHPUS

Helonias Dioica 2xHPUS

Agnus Castus 3XHPUS

Cimicifuga Racemosa 3xHPUS

Convalleria Majalis 3xHPUS

Crocus Sativus 3xHPUS

Cyclamen Europaeum 3xHPUS

Damiana 3xHPUS

Hydrastis Canadensis 3xHPUS

Caulophyllum Thalictroides 4xHPUS

Lilium Tigrinum 4xHPUS

Senecio Aureus 4xHPUS

Staphysagria 4xHPUS

Naja Tripudians 8xHPUS

The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

Purpose

OTC - PURPOSE SECTION

For fatigue, mental and physical exhaustion, PMS, depression and irritability.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Suggested use

INDICATIONS & USAGE SECTION

Adults take 1 tablespoon two to three times daily. Children 12 to 18 years of age take 1 teaspoon two to three times daily. Not intended for children under 12 years of age.

Warnings

WARNINGS SECTION

If pregnant or breast-feeding, consult a health professional before use. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

(Read Suggested Use Section)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ethyl Alcohol (20.9% by vol.) and Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

N29_60986-1033-7N29_60986-1033-7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60986-1033-72020-12-04C16284748780-19d75b9d0-9616-f424-e053-dadaa90a57ceDrug Facts
60986-1033-72020-01-31C16284748780-19d75b9d0-9616-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60986-1033-7Female Tonic236 mL in 1 BOTTLE, GLASSLIQUID2366

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60986-1033FEMALE TONIC (ALCHEMILLA VULGARIS, ASPERULA ODORATA, CHAMOMILLA, VIOLA ODORATA, CINCHONA OFFICINALIS, MENTHA PIPERITA, ROSMARINUS OFFICINALIS, VALERIANA OFFICINALIS, HELONIA DIOICA, AGNUS CASTUS, CIMICIFUGA RACEMOSA, CONVALLARIA MAJALIS, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, DAMIANA, HYDRASTIS CANADENSIS, CAULOPHYLLUM THALICTROIDES, LILIUM TIGRINUM, SENECIO AUREUS, STAPHYSAGRIA, NAJA TRIPUDIANS) LIQUID [MARCO PHARMA INTERNATIONAL LLC.]6Legacy NDC, 1 package rows20241206_5f87b864-c1c4-4362-9d7e-94937958d0ee.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60986-103360986-1033-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ALCHEMILLA XANTHOCHLORA FLOWERING TOP9M289NKI69ACTIB
GALIUM ODORATUMN8C4A9A49HACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
VIOLA ODORATAAET12U8B74ACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
MENTHA PIPERITA79M2M2UDA9ACTIB
ROSMARINUS OFFICINALIS FLOWERING TOP8JM482TI79ACTIB
VALERIANJWF5YAW3QWACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
CHASTE TREE433OSF3U8AACTIB
BLACK COHOSHK73E24S6X9ACTIB
CONVALLARIA MAJALISQHH4HVF5QEACTIB
SAFFRONE849G4X5YJACTIB
CYCLAMEN PURPURASCENS TUBERG728143D8QACTIB
TURNERA DIFFUSA LEAFY TWIGRQ2CFA7WWJACTIB
GOLDENSEALZW3Z11D0JVACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
LILIUM LANCIFOLIUM FLOWERING TOP6268MFA917ACTIB
PACKERA AUREA5WS1632J8WACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
286337e6-87f9-461c-e063-6394a90add965f87b864-c1c4-4362-9d7e-94937958d0ee2024-12-03WarningsExact identifier
spl id: 286337e6-87f9-461c-e063-6394a90add96
spl set id: 5f87b864-c1c4-4362-9d7e-94937958d0ee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.